CMS to providers: Prep for 2019-nCoV, stay CLIA compliant

By A.J. Plunkett

CMS is urging hospitals and other providers to review their plans for handling emerging diseases such as the 2019-nCoV coronavirus, while reminding surveyors that labs must remain CLIA compliant.

Late on February 6, CMS issued two Quality, Safety and Oversight group memos. The first reminds hospitals of requirements to follow basic infection control practices, such as the standard, contact, and airborne precautions recommended by the CDC.

The second warns surveyors to be on the lookout for clinical laboratories testing for 2019-nCoV that are not following manufacturer’s instructions or other requirements under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).

While many hospitals have clinical laboratories, something like the CDC assay for 2019-nCoV is most likely to go to state or public health laboratories anyway, notes Dan Scungio, MT(ASCP), SLS, laboratory safety officer for Sentara Healthcare in Virginia.

The day after CMS issued the two memos, the World Health Organization announced that while the number of new cases was slowing, it was concerned about the availability of protective masks and other supplies.

In QSO 20-09-ALL, CMS noted that healthcare organizations have been told to consider emerging infectious diseases as part of the all-hazards approach to emergency preparedness all healthcare providers have been required to follow since 2016.

The memo also notes that the CDC continues to issue information on the 2019-nCoV that began in China at the end of last year and has infected thousands, including more than 600 people who have died.

“CMS strongly urges the review of CDC’s guidance and encourages facilities to review their own infection prevention and control policies and practices to prevent the spread of infection,” said the memo. “To ensure health and safety, CMS also expects healthcare staff and surveyors (contractors, Federal, State, and Local) to comply with basic infection control practices,” and points to the CDC’s Interim Infection Control Recommendations for 2019-nCoV recommending standard, contact and airborne precautions.

“Healthcare staff should also adhere to CDC recommendations on standard hand hygiene practices, using alcohol-based hand rub/hand sanitizer (ABHR/ABHS) as the preferred method of hand hygiene in most clinical situations. If hands are visibly soiled, wash with soap and water for at least 20 seconds. Healthcare facilities should ensure that hand hygiene supplies are readily available,” according to CMS.

“In addition to the review of CDC information by healthcare facilities, we encourage the review of appropriate personal protective equipment (PPE) use and availability, such as gloves, gowns, respirators, and eye protection. CMS regularly observes these infection control practices as part of the normal survey process and notes that applying the basic principles of hand hygiene and using appropriate PPE protects lives.”

CMS also wants surveyors to look for clinical laboratories who are not following requirements for testing for the 2019-nCoV virus.

While the FDA, under HHS’ Emergency Use Authorization (EUA) of Medical Products, has authorized the “emergency use of in vitro diagnostics for detection and/or diagnosis of the novel coronavirus (2019-nCoV),” CMS says labs are still subject to CLIA requirements for performing high complexity tests and “laboratories must follow any and all manufacturer’s instructions.”

The CDC has said the diagnostic panel “is intended for use by laboratories designated by CDC as qualified, and in the United States, certified under the Clinical Laboratory Improvement Amendments (CLIA) to perform high complexity tests. This includes U.S. state and local public health laboratories and Department of Defense (DoD) laboratories.”

In its second memo, CMS further outlines that “the CDC 2019-nCoV Real-Time Reverse Transcriptase Polymerase Chain Reaction (rRT-PCR) assay is a molecular in vitro diagnostic test that aids in the detection of 2019-nCoV and is based on widely used nucleic acid amplification technology. The product contains oligonucleotide primers and dual-labeled hydrolysis probes and control material used in rRT-PCR for the in vitro presumptive qualitative detection of 2019-nCoV RNA in upper and lower respiratory specimens.”

“CMS has coordinated with the CDC to ensure the establishment of performance verification specifications for assays developed and tested by CDC. Subsequent assay performance verification on site at each CDC qualified laboratory is required,” says the memo, with the added warning that “inclusion as a CDC qualified laboratory, as defined in the assay’s Manufacturer’s Instructions (MI) for use, is not automatic, and members must demonstrate certain capabilities and capacities, and meet established agent specific performance standards.”

“Surveyors should determine if the laboratory is using an assay that has been authorized for emergency use by the FDA. Surveyors should notify their CMS Location if they discover a laboratory using an assay without an EUA that is testing for the same agent for which an emergency has been declared, or a modified EUA assay. The CMS Location will notify CMS Baltimore.”